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Senior MedTech Product Assurance Engineer

Job in Plymouth, Hennepin County, Minnesota, USA
Listing for: HistoSonics, Inc.
Full Time position
Listed on 2026-08-22
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 140000 USD Yearly USD 110000.00 140000.00 YEAR
Job Description & How to Apply Below

Histo Sonics, Inc. in Plymouth, MN, is seeking a Sr. Product Assurance Engineer to lead quality activities for commercial production, including inspection, product release, nonconforming material handling, and risk management coordination with Design Assurance.

The role collaborates with Manufacturing and Supply Chain to ensure compliance with FDA 21 CFR 820, ISO 13485 and ISO 14971, conducts PFMEA, participates in CAPAs, reviews DHRs, and supports supplier quality while traveling up to 10%.

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Position Requirements
10+ Years work experience
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